[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence pilot study of celecoxib capsules in healthy subjects under fasting and fed conditions
主要目的:以吉林亚泰永安堂药业有限公司研制的塞来昔布胶囊为受试制剂,以Pfizer Pharmaceuticals LLC生产的塞来昔布胶囊(商品名:西乐葆®)为参比制剂,考察空腹及餐后条件下塞来昔布胶囊的药代动力学参数,验证血药浓度分析方法以及采血时间、采样量等的合理性,初步评价两种制剂的生物等效性和个体内变异系数。
次要目的:评价中国健康受试者单次空腹/餐后口服塞来昔布胶囊受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Using celecoxib capsules developed by Jilin Yatai Yongantang Pharmaceutical Co., Ltd. as the test preparation and celecoxib capsules (trade name: Celebrex®) produced by Pfizer Pharmaceuticals LLC as the reference preparation, the pharmacokinetic parameters of celecoxib capsules under fasting and postprandial conditions were investigated, the rationality of the blood drug concentration analysis method, blood sampling time, sampling volume, etc., and the bioequivalence and intra-individual coefficient of variation of the two preparations were preliminarily evaluated.
Secondary purpose: To evaluate the safety of the test preparation and reference preparation of celecoxib capsules after a single fasting/postprandial oral administration in healthy Chinese subjects.